IGF::OT::IGF A National Clinical Laboratory Network for NCI Precision Oncology IGF::OT::IGF

Leidos Biomedical Research, Inc., Frederick MD

Investigators

Abstract

Scope or Objectives As a follow-up to the success of its initial precision oncology trials (NCI-MATCH and NCI-COG Pediatric MATCH), DCTD is developing a portfolio of clinical trials in the ET-CTN that will systematically identify new drugs to treat newly discovered molecular abnormalities of clinical significance. The product of this TORFP 17-090 A National Clinical Laboratory Network for NCI Precision Oncology 8/26/2017 Page 2 of 15 clinical trial portfolio is expected to be an increased number of molecular abnormalities that can be matched to targeted therapies ? a critical step in creating the treatment arms of the next generation MATCH-like trial. In addition, these ET-CTN trials will also assess drug molecular mechanism of action (mMOA) and reveal if the pharmacodynamics (PD) of each drug varies when matched to particular variants of the molecular abnormality. To conduct the ET-CTN portfolio trials, a precision oncology clinical trial laboratory network is needed to provide robust, specialized fit-for-purpose analyses of patient specimens with a reliability that will assure reproducible assay performance when the assays are incorporated into the next generation MATCH trial to assign patients to therapy. The MoCha lab and CPP (composed of PADIS, NCTVL and IQC labs) are requested to support a National Clinical Laboratory Network (NCLN) for Precision Oncology by establishing, participating in, leading and assuring the quality of a national network of clinical laboratories capable of providing robust, reliable and relevant clinical assays that are harmonized across laboratories. The NCLN will provide complete assay services (i.e. fit-for-purpose clinical assays) covering all required aspects of molecular characterization (including the Oncomine assay), diagnostic protein assays and pharmacodynamic assays of patient specimens in the ET-CTN. The NCLN must have the flexibility to incorporate newly developed clinical assays and assay technologies that are important for matching patients with targeted agents and work within different regulatory environments (CLIA or not). The clinical assay locations that comprise the NCLN will be available in time to contribute to all aspects of the selected NCI sponsored trials in the ET-CTN precision oncology portfolio: clinical protocol development; IRB (or cIRB) approval and activation of the trial; specimen collection, shipping, processing/handling, tracking and accountability; clinical sample analyses; quality controlled supply lines of key reagents and reference samples; proficiency testing and other quality assurance strategies; timely reporting of assay results to clinical sites; organized storage of cumulative assay results; and analysis and reporting of assay results to clinical investigators.